Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
NCT ID: NCT05969223
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
214 participants
INTERVENTIONAL
2023-08-10
2025-11-28
Brief Summary
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Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled across approximately 45 sites globally.
The study will be broken up into 2 studies by disease location, participants with moderate to severe genital psoriasis (Study-G) and moderate to severe scalp psoriasis (Study-S). In both studies participants will receive subcutaneous (SC) injections of risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab during the 16 week treatment period followed by SC injections of risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Study-G Placebo (Period A)
Participants with moderate to severe genital psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.
Placebo for Risankizumab
Subcutaneous injection
Study-G Risankizumab (Period A)
Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.
Risankizumab
Subcutaneous injection
Study-S Placebo (Period A)
Participants with moderate to severe scalp psoriasis received placebo for risankizumab subcutaneously at Weeks 0 and 4 during Period A.
Placebo for Risankizumab
Subcutaneous injection
Study-S Risankizumab (Period A)
Participants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously at Weeks 0 and 4 during Period A.
Risankizumab
Subcutaneous injection
Study-G Placebo/Risankizumab (Period B)
Participants with moderate to severe genital psoriasis received placebo for risankizumab during Period A, and 150 mg of risankizumab subcutaneously at Weeks 16, 28, and 40 during Period B.
Risankizumab
Subcutaneous injection
Study-G Risankizumab/Risankizumab (Period B)
Participants with moderate to severe genital psoriasis received 150 mg of risankizumab subcutaneously during Period A, and continued with this treatment at Weeks 16, 28, and 40 during Period B.
Risankizumab
Subcutaneous injection
Study-S Placebo/Risankizumab (Period B)
Participants with moderate to severe scalp psoriasis received placebo for risankizumab during Period A, and 150 mg of risankizumab subcutaneously at Weeks 16, 28, and 40 during Period B.
Risankizumab
Subcutaneous injection
Study-S Risankizumab/Risankizumab (Period B)
Participants with moderate to severe scalp psoriasis received 150 mg of risankizumab subcutaneously during Period A, and continued with this treatment at Weeks 16, 28, and 40 during Period B.
Risankizumab
Subcutaneous injection
Interventions
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Risankizumab
Subcutaneous injection
Placebo for Risankizumab
Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a current diagnosis of moderate to severe genital psoriasis (Study-G) defined as static Physician Global Assessment of Genitalia (sPGA-G) ≥ 3 or moderate to severe scalp psoriasis (Study-S) defined as Psoriasis Scalp Severity Index (PSSI) \>= 12, scalp Investigator Global Assessment (IGA) \>= 3, and \>= 30% of the scalp affected.
* Must have body surface area (BSA) ≥ 1% with at least 60% of subjects having BSA ≥ 10%; sPGA ≥ 3; inadequate control of psoriasis and/or intolerance to topical treatment, phototherapy and/or systemic therapy; and be candidates for systemic therapy or phototherapy as assessed by the investigator.
Exclusion Criteria
* History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
* Non-plaque forms of psoriasis or other active skin disease.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Medical Dermatology Specialists /ID# 262915
Phoenix, Arizona, United States
Alliance Dermatology and Mohs Center /ID# 255846
Phoenix, Arizona, United States
Banner University Medicine Dermatology /ID# 255845
Tucson, Arizona, United States
Private Practice - Dr. Tooraj Raoof /ID# 255334
Encino, California, United States
Dermatology Research Associates /ID# 255347
Los Angeles, California, United States
Clinical Trials Research Institute /ID# 264555
Thousand Oaks, California, United States
Florida Academic Dermatology Center /ID# 264065
Coral Gables, Florida, United States
Skin Care Research - Hollywood /ID# 255394
Hollywood, Florida, United States
GSI Clinical Research, LLC /ID# 255472
Margate, Florida, United States
Skin and Cancer Associates, LLP /ID# 255506
Miami, Florida, United States
Sullivan Dermatology /ID# 264067
Miami, Florida, United States
Renstar Medical Research /ID# 255339
Ocala, Florida, United States
Hamilton Research, LLC /ID# 255409
Alpharetta, Georgia, United States
Treasure Valley Medical Research /ID# 255671
Boise, Idaho, United States
DeNova Research /ID# 264063
Chicago, Illinois, United States
Arlington Dermatology /ID# 255330
Rolling Meadows, Illinois, United States
The Indiana Clinical Trials Center /ID# 255333
Plainfield, Indiana, United States
Dermatology Partners of Leawood /ID# 263244
Leawood, Kansas, United States
DermAssociates - Rockville /ID# 263252
Rockville, Maryland, United States
Skin Specialists /ID# 262929
Omaha, Nebraska, United States
Skin Cancer and Dermatology Institute (SCDI) /ID# 264570
Sparks, Nevada, United States
Care Access - Hoboken /ID# 264066
Hoboken, New Jersey, United States
Forest Hills Dermatology Group @ Union Turnpike /ID# 255346
Kew Gardens, New York, United States
Schweiger Dermatology, P.C. /ID# 255336
New York, New York, United States
Darst Dermatology /ID# 255848
Charlotte, North Carolina, United States
Wright State Physicians Health Center /ID# 255395
Fairborn, Ohio, United States
Apex Clinical Research Center /ID# 263432
Mayfield Heights, Ohio, United States
Oregon Dermatology and Research Center /ID# 255670
Portland, Oregon, United States
Oregon Medical Research Center /ID# 255332
Portland, Oregon, United States
Studies in Dermatology LLC /ID# 262989
Cypress, Texas, United States
Modern Research Associates /ID# 263234
Dallas, Texas, United States
Center for Clinical Studies - Houston (Binz) /ID# 255396
Houston, Texas, United States
U.S. Dermatology Partners Longview /ID# 266325
Longview, Texas, United States
Progressive Clinical Research - San Antonio /ID# 263255
San Antonio, Texas, United States
Center for Clinical Studies Webster TX /ID# 255518
Webster, Texas, United States
Care Access - Danville /ID# 266300
Danville, Virginia, United States
Center for Excellence in Dermatology /ID# 264647
Kennewick, Washington, United States
North Sound Dermatology /ID# 264565
Mill Creek, Washington, United States
Countries
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References
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Song EJ, Ehst B, Glick B, Lewitt GM, Rich P, Ezra N, Bagel J, Anschutz T, Bialik B, Duan C, Ashley D, Patel M, St John G, Setty AR, Ackerman L. Efficacy and Safety of Risankizumab in Genital or Scalp Psoriasis in the UnlIMMited Phase 4 Randomized Clinical Trial at Week 16. Dermatol Ther (Heidelb). 2025 Oct 25. doi: 10.1007/s13555-025-01544-6. Online ahead of print.
Related Links
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Other Identifiers
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2023-504154-35-00
Identifier Type: OTHER
Identifier Source: secondary_id
M23-702
Identifier Type: -
Identifier Source: org_study_id
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